Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2022375

FEI Number

2022375

Entity Name

UTAK LABORATORIES, INC.

City/State/Country

VALENCIA, CA, US

Establishment Address

25020 AVENUE TIBBITTS, VALENCIA, CA 91355, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

UTAK LABORATORIES, I (Owner Number: 2022375)

Owner / Operator Contact Address

25020 AVENUE TIBBITTS, --, Valencia, CA 91355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K831737

PMA Number

N/A

All Registered Proprietary Names

Cardiacs I Control Amoxapine Control Cardiacs II Control Hypnotics + Salicylate Control Tricyclic Antidepressants Control Maprotiline Control UTAK STABBS Control Tricyclic Antidepressants Control Trace Elements Control Clonazepam Control Disopyramide Control Whole Blood Lead Controls UTAK Toxicology Control Benzodiazepines Control TRICYLIC ANTIDEPRESSANTS Li Tx Control Caffeine Control TRICYLIC ANTIDEPRESSANTS Vi

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-05
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2016-10-19
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2007-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2016-10-19

Official Correspondent

Kevin Kopp

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UTAK LABORATORIES, I

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K803039	General Diagnostics	PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.	1980-12-22
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04

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1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2022375. Last updated year: 2026. Please use registration number 2022375 when referencing this establishment in official correspondence.